Family RelationsSIBTimeNCT04633473
SIB-Time Web-application Tool for Typically Developing Siblings
A study testing SIB-Time Web-Application Tool in people with Family Relations and Sibling Relations, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial summary
In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Relations, Sibling Relations
- What is being tested?
- SIB-Time Web-Application Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be the primary parent/guardian of a child with a disability
- Also be the primary parent/guardian of a typically developing child, 3-5 years old
- Speak English or Spanish
- Have access to a computer, tablet, or smartphone
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Eugene, Oregon, 97403
About this study
Official title: SIBTime: Media-enhanced Technology for Promoting the Behavioral Health and Family Relationships of Typically Developing Young Siblings
In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands. Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges. The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.
Read the detailed description
The investigators conducted a 4-week intervention to assess the English/Spanish, media-enhanced SIBTime web-application tool in terms of its relevance, acceptability, cultural appropriateness, and potential for efficacy to deliver a family-based intervention. The test used a within subjects pre-post design to detect changes in parent self-efficacy, family cohesion, and knowledge, and parent rating of sibling-parent relationship. Additionally, the investigators collected a post-test evaluation of consumer satisfaction and recommendations for modifications to the program.
- Conditions
- Family Relations, Sibling Relations
- Being tested
- SIB-Time Web-Application Tool
- Keywords
- Social Emotional Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIB-Time Web-Application ToolBehavioural
Also called SIBTime
Parents used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, parents used the app at their convenience.
| Study group | Role | What they receive |
|---|---|---|
| SIBTime | Experimental | 43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion). Receives: Behavioral: SIB-Time Web-Application Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) Parent/Child Relationship subscale measures the quality of the parent-child relationship, asking how true various statements have been over the past 4 weeks. The Parent/Child Relationship subscale is measured with 5 items, answered on a 5-point scale (0=Not at all; 4=Very much). Average scores range from 0 to 4, with higher scores indicating worse outcomes.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Emotional Availability subscale measures parents' self-efficacy for providing emotional support to their typically developing child and meeting their child's emotional needs. Parents rate their agreement or disagreement with a series of statements. The SEPTI Emotional Availability subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Nurturance/Valuing/Empathic Responsiveness subscale measures parents' self-efficacy for providing empathy, nurturance, and understanding to their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Nurturance/Valuing/Empathic Responsiveness subscale is measured with 8 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Play subscale measures parents' self-efficacy for playing with and having fun with their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Play subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Teaching subscale measures parents' self-efficacy for explaining things and teaching their typically developing child about the world in a way that their child can understand. Parents rate their agreement or disagreement with a series of statements. The SEPTI Teaching subscale is measured with 9 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Measured: Enrollment, and at 4 weeks (after treatment completion)
System Usability Scale (SUS)
The System Usability Scale (SUS) is a commonly used 10-item measure (with a 5-point scale) of subjective perceptions of technology usability. To calculate the total SUS score, the responses to all 10 SUS questions are re-scaled and/or re-scored in a way that all items had values from zero to 4 with 4 being the most positive. These converted scores are added and then multiplied by 2.5 to convert the range of possible values 0-100 (instead of from 0 to 40). Higher scores are better.
Measured: Week 4
Secondary outcomes (4)
Engagement in Target Activities With Child - Frequency
The Engagement in Target Activities with Child - Frequency subscale measures the frequency with which parents report engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors. Respondents answer on a 7-point frequency scale (0=Never in the past month; 6=6 or more times per day); average scores range from 0 to 6, with higher scores indicating better outcomes.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Engagement in Target Activities With Child - Self-efficacy
The Engagement in Target Activities with Child - Self-Efficacy subscale measures parents' self-efficacy for engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors. Respondents answer on a 10-point scale of how confident they are that they can carry out these behaviors (1=Not at all confident; 10=Highly confident); average scores range from 1 to 10, with higher scores indicating better outcomes.
Measured: Enrollment, and at 4 weeks (after treatment completion)
Family Usage of the SIBTime App - Number of Sessions
Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
Measured: At 4 weeks (after treatment completion)
Family Usage of the SIBTime App - Program Exposure
Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
Measured: At 4 weeks (after treatment completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start9 Jun 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Family RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Research Institute
- Responsible party
- Sponsor
- Investigators
- Patricia Vadasy, Ph.D., Principal investigator, Oregon Research Behavioral Interventions Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633473
- Sponsor's protocol ID
- MD015947
- Acronym
- SIBTime
- Status last verified
- Jan 2024
- First submitted
- 28 Oct 2020
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIBTime: Media-enhanced Technology for Promoting the Behavioral Health and Family Relationships of Typically Developing Young Siblings
- ClinicalTrials.gov ID
- NCT04633473
- Acronym / sponsor ID
- SIBTime / MD015947
- Conditions
- Family Relations, Sibling Relations
- Keywords
- Social Emotional Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Oregon Research Institute
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands. Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges. The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.
Detailed description
The investigators conducted a 4-week intervention to assess the English/Spanish, media-enhanced SIBTime web-application tool in terms of its relevance, acceptability, cultural appropriateness, and potential for efficacy to deliver a family-based intervention. The test used a within subjects pre-post design to detect changes in parent self-efficacy, family cohesion, and knowledge, and parent rating of sibling-parent relationship. Additionally, the investigators collected a post-test evaluation of consumer satisfaction and recommendations for modifications to the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIBTime | Experimental | Behavioral: SIB-Time Web-Application Tool43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be the primary parent/guardian of a child with a disability
- Also be the primary parent/guardian of a typically developing child, 3-5 years old
- Speak English or Spanish
- Have access to a computer, tablet, or smartphone
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIB-Time Web-Application ToolAlso: SIBTimeParents used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, parents used the app at their convenience. | Behavioural | SIBTime |
Primary outcome
Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale
Time frame: Enrollment, and at 4 weeks (after treatment completion)
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) Parent/Child Relationship subscale measures the quality of the parent-child relationship, asking how true various statements have been over the past 4 weeks. The Parent/Child Relationship subscale is measured with 5 items, answered on a 5-point scale (0=Not at all; 4=Very much). Average scores range from 0 to 4, with higher scores indicating worse outcomes.
Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale
Time frame: Enrollment, and at 4 weeks (after treatment completion)
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale
Time frame: Enrollment, and at 4 weeks (after treatment completion)
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale
Time frame: Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Emotional Availability subscale measures parents' self-efficacy for providing emotional support to their typically developing child and meeting their child's emotional needs. Parents rate their agreement or disagreement with a series of statements. The SEPTI Emotional Availability subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale
Time frame: Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Nurturance/Valuing/Empathic Responsiveness subscale measures parents' self-efficacy for providing empathy, nurturance, and understanding to their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Nurturance/Valuing/Empathic Responsiveness subscale is measured with 8 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale
Time frame: Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Play subscale measures parents' self-efficacy for playing with and having fun with their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Play subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale
Time frame: Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Teaching subscale measures parents' self-efficacy for explaining things and teaching their typically developing child about the world in a way that their child can understand. Parents rate their agreement or disagreement with a series of statements. The SEPTI Teaching subscale is measured with 9 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
System Usability Scale (SUS)
Time frame: Week 4
The System Usability Scale (SUS) is a commonly used 10-item measure (with a 5-point scale) of subjective perceptions of technology usability. To calculate the total SUS score, the responses to all 10 SUS questions are re-scaled and/or re-scored in a way that all items had values from zero to 4 with 4 being the most positive. These converted scores are added and then multiplied by 2.5 to convert the range of possible values 0-100 (instead of from 0 to 40). Higher scores are better.
4 secondary outcomes
Engagement in Target Activities With Child - Frequency
Time frame: Enrollment, and at 4 weeks (after treatment completion)
Engagement in Target Activities With Child - Self-efficacy
Time frame: Enrollment, and at 4 weeks (after treatment completion)
Family Usage of the SIBTime App - Number of Sessions
Time frame: At 4 weeks (after treatment completion)
Family Usage of the SIBTime App - Program Exposure
Time frame: At 4 weeks (after treatment completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Vadasy, Ph.D. principal investigator
Oregon Research Behavioral Interventions Strategies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIB-Time Web-Application Tool in people with Family Relations and Sibling Relations, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale (time frame: Enrollment, and at 4 weeks (after treatment completion)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.